Preventing Mid- and Later-Life Work Limitations

Depression Clinical Trial

Official title:

Preventing Mid- and Later-Life Work Limitations: Community-Based Depression Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163890
• Other study ID #: 1R01AG033125-01A1
• Status: Completed
• Phase: N/A
• First received: July 14, 2010
• Last updated: April 7, 2014
• Start date: September 2009
• Est. completion date: June 2013

Study information

• Verified date: April 2014
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The Work and Health Initiative (WHI) trial is testing an innovative, community-based program that provides mental health and vocational services to workers 50 years or older to improve functioning and reduce productivity loss. The purpose of this study is to test the hypothesis that relative to usual care, the WHI improves the work outcomes of depression and reduces depression-related productivity loss.

Description:

National demographic, economic and cultural trends are creating a need for hiring and retaining older workers. However, while many older people will prefer and/or need to work, chronic health problems occurring in mid-life or later can severely disrupt employment. This study will conduct a randomized controlled trial (RCT) of the Work and Health Initiative (WHI). The WHI is an innovative community-based program that provides mental health and vocational services to workers with depression to improve functioning and reduce productivity loss. This study will focus on workers 50 years of age and older. This study will test the hypothesis that relative to usual care, the WHI improves the work outcomes of depression. Study results potentially will result in a new multi-disciplinary method for addressing a serious public health and employment issue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• age = 45 years

• working = 15 hours/week

• DSM-IV current major depression and/or dysthymia

• Work limitations: at-work productivity loss score = 5%

Exclusion Criteria:

• severe physical health deficits

• non-English speaking or reading

• positive current alcoholism screening

• psychosis

• mania

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Work and Health Initiative
Telephone-based multi-modal intervention, consisting of: vocational coaching, cognitive-behavioral therapy strategies and care coordination strategies provided by specially-trained EAP counselors
• Usual Medical or Behavioral Intervention
Referral to treatment as usual through personal physician, mental health professional, behavioral health program, and/or Employee Assistance Program

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	OptumHealth Behavioral Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At-work performance deficits and productivity loss as measured by the Work Limitations Questionnaire		4 months post-randomization	No
Primary	Absenteeism and productivity loss as measured by the Work Limitations Questionnaire Absence Module		4 months post-randomization	No
Secondary	Depression symptom severity as measured by the Patient Health Questionnaire (PHQ-9)		4 months post-randomization	No

External Links

•   WHI Study Website